Comparative effectiveness of initial computed tomography and invasive coronary angiography in women and men with stable chest pain and suspected coronary artery disease: multicentre randomised trial
Authors: Klaus F Kofoed, Maria Bosserdt, Pál Maurovich-Horvat, Nina Rieckmann, Theodora Benedek, Patrick Donnelly, José Rodriguez-Palomares, Andrejs Erglis, Cyril Štěchovský, Gintarė Šakalytė, Filip Ađić, Matthias Gutberlet, Jonathan D Dodd, Ignacio Diez, Gershan Davis, Elke Zimmermann, Cezary Kępka, Radosav Vidakovic, Marco Francone, Małgorzata Ilnicka-Suckiel, Fabian Plank, Juhani Knuuti, Rita Faria, Stephen Schröder, Colin Berry, Luca Saba, Balazs Ruzsics, Christine Kubiak, Kristian Schultz Hansen, Jacqueline Müller-Nordhorn, Bela Merkely, Tem S Jørgensen, Imre Benedek, Clare Orr, Filipa Xavier Valente, Ligita Zvaigzne, Vojtěch Suchánek, Laura Zajančkauskienė, Milenko Čanković, Michael Woinke, Stephen Keane, Iñigo Lecumberri, Erica Thwaite, Michael Laule, Mariusz Kruk, Aleksandar N Neskovic, Massimo Mancone, Donata Kuśmierz, Gudrun Feuchtner, Mikko Pietilä, Vasco Gama Ribeiro, Tanja Drosch, Christian Delles, Bruno Loi, Michael Fisher, Bálint Szilveszter, Per E Sigvardsen, Mihaela Ratiu, Stephanie Kelly, Bruno Garcia Del Blanco, Ainhoa Rubio, Zsófia D Drobni, Charlotte Kragelund, Ioana Rodean, Susan Regan, Hug Cuéllar Calabria, Melinda Boussoussou, Thomas Engstrøm, Roxana Hodas, Adriane E Napp, Robert Haase, Sarah Feger, Mahmoud M A Mohamed, Lina M Serna-Higuita, Konrad Neumann, Henryk Dreger, Matthias Rief, Viktoria Wieske, Melanie Estrella, Peter Martus, Marc Dewey
Journal: BMJ (2022)

To assess the comparative effectiveness of computed tomography and invasive coronary angiography in women and men with stable chest pain suspected to be caused by coronary artery disease. Prospective, multicentre, randomised pragmatic trial. Hospitals at 26 sites in 16 European countries. 2002 (56.2%) women and 1559 (43.8%) men (total of 3561 patients) with suspected coronary artery disease referred for invasive coronary angiography on the basis of stable chest pain and a pre-test probability of obstructive coronary artery disease of 10-60%. Both women and men were randomised 1:1 (with stratification by gender and centre) to a strategy of either computed tomography or invasive coronary angiography as the initial diagnostic test (1019 and 983 women, and 789 and 770 men, respectively), and an intention-to-treat analysis was performed. Randomised allocation could not be blinded, but outcomes were assessed by investigators blinded to randomisation group. The primary endpoint was major adverse cardiovascular events (MACE; cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke). Key secondary endpoints were an expanded MACE composite (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, transient ischaemic attack, or major procedure related complication) and major procedure related complications. Follow-up at a median of 3.5 years was available in 98.9% (1979/2002) of women and in 99.0% (1544/1559) of men. No statistically significant gender interaction was found for MACE (P=0.29), the expanded MACE composite (P=0.45), or major procedure related complications (P=0.11). In both genders, the rate of MACE did not differ between the computed tomography and invasive coronary angiography groups. In men, the expanded MACE composite endpoint occurred less frequently in the computed tomography group than in the invasive coronary angiography group (22 (2.8%) v 41 (5.3%); hazard ratio 0.52, 95% confidence interval 0.31 to 0.87). In women, the risk of having a major procedure related complication was lower in the computed tomography group than in the invasive coronary angiography group (3 (0.3%) v 21 (2.1%); hazard ratio 0.14, 0.04 to 0.46). This study found no evidence for a difference between women and men in the benefit of using computed tomography rather than invasive coronary angiography as the initial diagnostic test for the management of stable chest pain in patients with an intermediate pre-test probability of coronary artery disease. An initial computed tomography scan was associated with fewer major procedure related complications in women and a lower frequency of the expanded MACE composite in men. NCT02400229ClinicalTrials.gov NCT02400229.